NA 37022 (UDI 00643169513013)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169513013), received between Dec 1, 2016 and May 3, 2024 — classified as 9 injuries, 11 malfunctions.

The most frequently reported specific device problem is “High impedance” (10 reports).

28 other recalls cover devices cleared under the same FDA submission (P840001, P960009); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2024High impedance; High impedance

  IT WAS REPORTED THAT PATIENT HAS HIGH IMPEDANCES ON ALL CONTACTS ON THE LEFT LEAD AND HIGH IMPEDANCES ON THE MOST VENTRAL CONTACT OF THE RIGHT LEAD. PATIENT DESCRIBED HAVING A FEW FALLS SINCE IMPLANT IN 2009. DURING BATTERY REPLACEMENT SURGERY, BATTERY WAS REPLACED, IMPEDANCES TESTED, ADAPTOR REPLACED, AND LASTLY LEADS WERE TESTED USING A TEST CABLE TO IDENTIFY WHETHER IT WAS AN ISSUE WITH THE LEADS OR EXTENSIONS. IT WAS DISCOVERED THAT IT IS A LEAD ISSUE. PLANNED AN EXPLANT/REIMPLANT ON (B)(6) 2024. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239112 ↗
• MalfunctionOct 6, 2023High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER, REPORTED THE CAUSE OF THE OPEN CIRCUITS WAS DUE TO THE LEAD NOT BEING FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884628 ↗
• MalfunctionJun 15, 2023High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE IMPEDANCE AND CLIP ISSUE WASN¿T DETERMINED, BUT THERE WAS NO IMPEDANCE ISSUE AT THE PATIENT¿S STAGE 2 PROCEDURE, AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138117 ↗
• InjuryJun 13, 2023High impedance; Connection Problem; High impedance; Connection Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE PATIENT RECOVERED FROM THE EXPLANT OF THE ORIGINAL LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17120689 ↗
• InjuryMar 14, 2023High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED IMPEDANCES WERE ALL OVER 10,000. AN FHC 66-IT-AR4P WAS USED DURING THE PROCEDURE. THE ISSUE WAS RESOLVED AFTER REPLACING THE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539266 ↗
• MalfunctionFeb 6, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE GOT A SHORT CIRCUIT FOR MONOPOLAR IMPEDANCE FOR 3 ELECTRODES, 280/290/LOW. BIPOLAR IMPEDANCE WAS FINE. REP SAID THEY HAD CHANGED THE ENS AND WERE USING A NEW LEAD. TECHNICAL SERVICES(TS) RECOMMEND TWISTING THE TEST CABLE WITH LEAD IN IT AND TRYING AGAIN. IMPEDANCE CHECK FOR NORMAL ONCE HCP TWISTED THE TEST CABLE WITH LEAD INSIDE. ISSUE RESOLVED. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303258 ↗
• InjuryDec 7, 2022High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LEAD WAS IMPLANTED AND THE LEAD GOT ALL HIGH IMPEDANCES. THE SCREENING CABLE WAS TWISTED ON THE LEAD MULTIPLE TIMES, PUSH THE STYLET ALL THE WAY IN, AND REINSERTED THE LEAD TEST CABLE RUNNING A TEST MULTIPLE TIMES WITH NO FIX. THE MANUFACTURER REPRESENTATIVE OPENED UP ANOTHER LEAD TEST CABLE TO SEE IF THAT WAS FAULTY, AND THEY WERE STILL ALL HIGH. THE MANUFACTURER REPRESENTATIVE THEN GOT A NEW LEAD, USED THE SECOND TEST CABLE AND EVERYTHING CAME BACK NORMAL. A NEW TEST CABLE WAS TRIED BEFORE THE NEW LEAD. ON THE FIRST LEAD AND TEST CABLE, THE TEST CABLE WAS REINSERTED MANY TIMES. IT WAS ALSO CONFIRMED IT WAS FULLY INTERRED USING THE MARKERS ON THE TEST CABLE BOX BY THE BLUE ARROWS. THERE ARE NO KNOWN ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. 2022-12-02 (REP, HCP): ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE HIGH IMPEDANCE WAS ASSUMED TO BE A FAULTY LEAD, ALTHOUGH IT SEEMED HIGHLY UNLIKELY. THE REP TRIED USING TWO TEST CABLES AND TRIED RECONNECTING BOTH CAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936176 ↗
• InjuryNov 18, 2022Break; Electromagnetic Interference; Low impedance; Break; Electromagnetic Interference; Low impedance

  IT WAS REPORTED THAT THERE WERE LOW IMPEDANCE VALUES/POTENTIAL SHORT FOR BIPOLOAR IMPEDANCES ON LEFT HEMISPHERE LEAD DURING STAGE 2 IMPLANT. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE IDENTIFIED. SURGICAL INTERVENTION IS PLANNED TO REPLACE THE LEFT HEMISPHERE LEAD. DURING THE STAGE 2 IMPLANT PROCEDURE, THE PROXIMAL PART OF THE LEFT HEMISPHERE LEAD WAS CAUGHT IN THE PATIENT'S TISSUE. THE PHYSICIAN USED CAUTERY TO FREE THE LEAD FROM THE TISSUE. WHEN IMPEDANCES WERE TESTED FOR THAT LEAD, THE BIPOLAR IMPEDANCES SHOWED SHORTS BETWEEN CONTACT 2A AND 1A, AND ALSO BETWEEN 1A AND 0. THEREFORE THE LEAD WAS TESTED VIA A LEAD TEST CABLE AND SHOWED SIMILAR IMPEDANCES ISSUES (SHORTS FOR BIPOLAR IMPEDANCES FOR THE COMBINATION OF 2A AND ALL OTHER CONTACTS). THE END OF THE LEAD WAS WIPED WITH A STERILE 4X4, AND THE LEAD WAS ADJUSTED IN THE LEAD TEST CABLE, AND THE LEAD WAS ALSO RECONNECTED TO THE EXTENSION AND TESTED IMPEDANCES AT THE BATTERY SITE. SIMILAR RESULTS WERE OBSERVED WITH THE IMPEDANCES WITH EVERY TEST. FINALLY, THE PHYSICIAN SURMISED THAT HE MAY HAVE BROKEN THE INSULATION OF THE LEAD IN THAT AREA WHERE HE HAD CAUTERIZED TO FREE IT FROM T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824869 ↗
• InjuryApr 20, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE (REP) IN THE OR IMPLANTING SENSIGHT LEADS AND TESTING WITH THE EXTERNAL NEUROSTIMULATOR (ENS) WITH THE HCP. THE CALLER STATED THAT THEY TESTED LEADS IN SALINE OUTSIDE OF THE BODY AND ALL IMPEDANCES ARE GOOD BUT WHEN PLACED IN THE BRAIN, THE CALLER WAS GETTING HIGH IMPEDANCES, SPECIFICALLY SEGMENTED CONTACTS 1 AND 2 OUT OF RANGE. CALLER STATED THEY TRIED OTHER LEADS AND OTHER TESTING CABLE BUT IT DIDN'T RESOLVE WHEN THE LEADS WERE PLACED IN THE BRAIN. CALLER SAID THE READINGS SEEMED ERRATIC. CALLER WAS ADVISED TO WIPE LEADS AND TRY AGAIN--THIS TIME BIPOLAR CONTACTS ASSOCIATED WITH 2A WERE OUT OF RANGE 14-24K OHMS 2A/0 2A/1 2A/2. TECHNICAL SERVICES (TS) HAD CALLER CREATE PROGRAM ON 2A/0 SIMPLE BIPOLE AND THERAPY IMPEDANCE SHOWED READING OF 2350OHMS. TECHNICAL SERVICES SPECIALIST (TSS) BROUGHT ON ANOTHER TSS AND THEY NOTED THEY HAVE SEEN WHERE SEGMENTED LEADS IN NORMAL IMPEDANCE TEST SHOW HIGH BUT WHEN ISOLATED VIA THERAPY IMPEDANCE, THEY REFLECT NORMAL AND THEY SHOULD BE GOOD TO IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160055 ↗
• InjuryFeb 11, 2022High impedance; High impedance

  IT WAS REPORTED THAT DURING STAGE 1 INTRA OP PROCEDURE, IMPEDANCES WERE "HIGH" ON CONTACTS 1A, 2A (BIPOLAR) ON THREE SEPARATE LEADS AND 2 TESTING CABLES. THE MANUFACTURER'S REPRESENTATIVE (REP) REVIEWED THAT THEY MADE SURE THAT THE TABLET WAS SET UP WITH THE CORRECT SET UP WITH THE EXTERNAL NEUROSTIMULATOR (ENS) CHOSEN AND THE CORRECT LEAD MODEL NUMBERS. THEY MADE SURE THE STYLET WAS FULLY PUSHED IN, ROTATED THE TESTING CABLE, RAN STIMULATION TO THE AFFECTED CONTACTS AND THEN TESTED BOTH MONOPOLAR AND BIPOLAR IMPEDANCES.  WE THEN RAN A THERAPY IMPEDANCE FOR CONTACTS 1 AND 2 AND THEY WERE CLEAR. IMPEDANCES WERE NOT COMING DOWN. TS HAD THEM RUN A THERAPY IMPEDANCE WHILE PROGRAMMED ON CONTACTS 1A, 2A AND SHOWED VALUE AT 1397 OHMS. ON LEAD (IMPLANTED) THERAPY IMPEDANCE WAS 1,627 OHMS (COMPLETELY NORMAL RANGE) AND ON LEAD (IMPLANTED) THERAPY IMPEDANCE WAS 1,221 OHMS (COMPLETELY NORMAL RANGE). THE THERAPY IMPEDANCES WERE THE INFORMATION USED TO PROMPT THE SURGEON TO MOVE FORWARD WITH THE IMPLANT. THE REP THOUGHT THE ENS MAY HAVE BEEN THE ISSUE AS IT WAS THE ONLY CONSTANT IN ALL THE TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518420 ↗
• InjuryFeb 4, 2022High impedance; High impedance

  IT WAS REPORTED THAT DURING STAGE 1 LEAD IMPLANT, REPORTED ONE SIDE TESTED GOOD, BURIED LEAD AND WENT TO THE OTHER SIDE IMPLANTED LEAD AND FOUND SEGMENT 2A AND 2B >30,000 OHMS. AN ATTEMPT WAS MADE TO RESOLVE THE ISSUE, BY REPLACING TABLET, ENS, CABLE AND THEN LEAD. CALLER REACHED OUT TO TECHNICAL SERVICES AFTER LEAD REPLACEMENT, AND NOW 2B AND 2C ARE >30 ,000 OHMS. IT WAS DECIDED TO IMPLANT LEAD AND CHECK IMPEDANCES WHEN INS IS CONNECTED. CALLER NEEDED TO DISCONNECT CALL - WILL EMAIL REP TO GET REQUIRED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453102 ↗
• MalfunctionJul 21, 2020Unable to Obtain Readings; Insufficient Device Problem Information; Unable to Obtain Readings; Insufficient Device Problem Information

  THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THROUGH A MANUFACTURER REPRESENTATIVE THAT ¿THERE WAS A PROBLEM WITH THE LEAD¿ AND THAT THEY WERE ¿UNABLE TO MEASURE RESISTANCE.¿ ADDITIONAL INFORMATION RECEIVED STATED THAT ¿UNABLE TO MEASURE RESISTANCE¿ REFERRED TO INVALID RESISTANCE READINGS. THE LEAD WAS REPLACED AS A RESULT OF THE EVENT AND THE ISSUE WAS RESOLVED. THERE WERE NO SURGICAL INTERVENTIONS PLANNED OR PERFORMED AND THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10301390 ↗
• InjuryMar 1, 2019Break; Impedance Problem; Insufficient Device Problem Information; Break; Impedance Problem; Insufficient Device Problem Information

  IT WAS REPORTED THE LEAD COULD NOT BE USED NORMALLY AND THE RESISTANCE COULD NOT BE MEASURED. THERE WERE NO EXTERNAL FACTORS REPORTED TO HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ¿WHOLE LINK¿ WAS CHECKED WITH NO PROBLEM FOUND AND THE ¿CABLE WAS NO PROBLEM,¿ SO THE LEAD WAS REPLACED. IT WAS STATED THAT A SURGICAL INTERVENTION OCCURRED WHERE BY THE LEAD WAS REPLACED AND THE OPERATION WAS COMPLETED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF REPORT. IT WAS NOTED THAT SINCE LEAD REPLACEMENT RESOLVED THE ISSUE, ¿IT WAS CONCLUDED THAT THE LEAD WAS BROKEN.¿ THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT; NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8383734 ↗
• MalfunctionMar 13, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  STUDY ARTICLE SUMMARY: THE STUDY AIMED TO DETERMINE THE FEASIBILITY OF POLYMODAL MODULATION THERAPY IN SUBJECTS WITH CHRONIC INTRACTABLE LOWER BACK PAIN WITH OR WITHOUT LEG PAIN. THE AUTHORS CONCLUDED THAT THE RESULTS OF THE STUDY CONFIRMED THE FUNCTIONALITY, EFFICACY, AND SAFETY OF PM-SCS IN A TRIAL PHASE STIMULATION PERIOD. REPORTED EVENT: 1 PATIENT ((B)(6)) EXPERIENCED LEAD MOVEMENT THAT WAS ¿DEFINITELY¿ PROCEDURE OR DEVICE RELATED. THE EVENT SEVERITY WAS CONSIDERED MODERATE AND THE ISSUE WAS RESOLVED WITHIN ONE DAY THROUGH LEAD REMOVAL. IT WAS NOTED THE PATIENT¿S LEADS WERE TAKEN OUT ON (B)(6) 2017. IT WAS NOTED THE PATIENT HAD ENROLLED IN THE STUDY ON (B)(6) 2017 AND WITHDREW FROM THE STUDY ON (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED FROM THE STUDY¿S DIRECTOR OF RESEARCH REPORTED THAT X-RAY IMAGING REVEALED THE LEADS HAD MOVED TO A LOCATION THAT RENDERED THERAPY INEFFECTIVE. IT WAS NOTED THE EVENT STARTED ON (B)(6) 2017 AND WAS RESOLVED ON (B)(6) 2017 AFTER THE LEADS WERE REMOVED. THOUGH IT WAS REPORTED THE EVENT WAS NOT UNANTICIPATED, IT WAS NOTED THE CAUSE OF THE EVENT WAS NOT CLEARLY DETERMINED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. PLEASE NOTE THE FIRS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7336262 ↗
• MalfunctionMar 13, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  STUDY ARTICLE SUMMARY: THE STUDY AIMED TO DETERMINE THE FEASIBILITY OF POLYMODAL MODULATION THERAPY IN SUBJECTS WITH CHRONIC INTRACTABLE LOWER BACK PAIN WITH OR WITHOUT LEG PAIN. THE AUTHORS CONCLUDED THAT THE RESULTS OF THE STUDY CONFIRMED THE FUNCTIONALITY, EFFICACY, AND SAFETY OF PM-SCS IN A TRIAL PHASE STIMULATION PERIOD. REPORTED EVENTS: ONE PATIENT (B)(4) EXPERIENCED LEAD MOVEMENT THAT WAS ¿DEFINITELY¿ PROCEDURE OR DEVICE RELATED. THE EVENT SEVERITY WAS CONSIDERED MILD AND WAS RESOLVED WITH REPROGRAMMING ONE DAY AFTER THE EVENT. IT WAS NOTED THAT AN X-RAY WAS PERFORMED TO CHECK THE LEAD POSITION AND THE PATIENT WAS REPROGRAMMED ACCORDINGLY. ADDITIONAL INFORMATION RECEIVED FROM THE STUDY¿S DIRECTOR OF RESEARCH REPORTED THE PATIENT WAS REPROGRAMMED ON (B)(6) 2017 AFTER X-RAY IMAGING AND THE ISSUE WAS RESOLVED; THE REPROGRAMMING PROVIDED OPTIMAL PAIN RELIEF. IT WAS NOTED THE EVENT STARTED ON (B)(6) 2017. THOUGH IT WAS REPORTED THE EVENT WAS NOT UNANTICIPATED, IT WAS NOTED THE CAUSE OF THE EVENT WAS NOT CLEARLY DETERMINED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. PLEASE NOTE THE FIRST PARAGRAPH OF THE REPORTED EVENT WAS INITIALLY REPORTED IN REGULATORY REPORT 300756

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7336164 ↗
• MalfunctionMar 13, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  STUDY ARTICLE SUMMARY: THE STUDY AIMED TO DETERMINE THE FEASIBILITY OF POLYMODAL MODULATION THERAPY IN SUBJECTS WITH CHRONIC INTRACTABLE LOWER BACK PAIN WITH OR WITHOUT LEG PAIN. THE AUTHORS CONCLUDED THAT THE RESULTS OF THE STUDY CONFIRMED THE FUNCTIONALITY, EFFICACY, AND SAFETY OF PM-SCS IN A TRIAL PHASE STIMULATION PERIOD. REPORTED EVENT: ONE PATIENT (B)(6) EXPERIENCED LEAD MOVEMENT THAT WAS ¿DEFINITELY¿ PROCEDURE OR DEVICE RELATED. THE EVENT SEVERITY WAS CONSIDERED MILD AND WAS RESOLVED WITH REPROGRAMMING 2 DAYS AFTER THE EVENT. IT WAS NOTED THE PATIENT¿S ¿LEADS HAD MOVED DOWN¿ AND THE SUBJECT EXITED FROM THE STUDY. IT WAS NOTED THE PATIENT HAD ENROLLED IN THE STUDY ON (B)(6) 2017 AND WITHDREW FROM THE STUDY ON (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED FROM THE STUDY¿S DIRECTOR OF RESEARCH REPORTED THAT X-RAY IMAGING PERFORMED ON (B)(6) 2017 INDICATED THE LEADS HAD MOVED DOWN TO A LOCATION THAT WOULD NOT PROVIDE OPTIMAL PAIN RELIEF. IT WAS NOTED THE EVENT HAD STARTED ON (B)(6) 2017 AND WAS RESOLVED ON (B)(6) 2017 AFTER THE PATIENT¿S TRIALING LEADS WERE REMOVED. THOUGH IT WAS REPORTED THE EVENT WAS NOT UNANTICIPATED, IT WAS NOTED THE CAUSE OF THE EVENT WAS NOT CLEARLY DETERMI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7335670 ↗
• MalfunctionMar 13, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  STUDY ARTICLE SUMMARY: THE STUDY AIMED TO DETERMINE THE FEASIBILITY OF POLYMODAL MODULATION THERAPY IN SUBJECTS WITH CHRONIC INTRACTABLE LOWER BACK PAIN WITH OR WITHOUT LEG PAIN. THE AUTHORS CONCLUDED THAT THE RESULTS OF THE STUDY CONFIRMED THE FUNCTIONALITY, EFFICACY, AND SAFETY OF PM-SCS IN A TRIAL PHASE STIMULATION PERIOD. REPORTED EVENTS: 1 PATIENT ((B)(6)) EXPERIENCED LEAD MOVEMENT THAT WAS ¿DEFINITELY¿ PROCEDURE OR DEVICE RELATED. THE EVENT SEVERITY WAS CONSIDERED MODERATE AND WAS RESOLVED WITH REPROGRAMMING 1 DAY AFTER THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE STUDY¿S DIRECTOR OF RESEARCH REPORTED THE LEAD MOVEMENT WAS CONFIRMED WITH X-RAY IMAGING AND THAT THE EVENT WAS RESOLVED ON (B)(6) 2017; REPROGRAMMING PROVIDED OPTIMAL PAIN RELIEF. IT WAS NOTED THE EVENT STARTED ON (B)(6) 2017. THOUGH IT WAS REPORTED THE EVENT WAS NOT UNANTICIPATED, IT WAS NOTED THE CAUSE OF THE EVENT WAS NOT CLEARLY DETERMINED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. PLEASE NOTE THE FIRST PARAGRAPH OF THE REPORTED EVENT WAS INITIALLY REPORTED IN REGULATORY REPORT 3007566237-2017-04865, BUT HAS SINCE BEEN SPLIT INTO THIS SEPARATE REGULATORY REPORT DUE TO THE RECEIPT OF UNIQUE I

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7335411 ↗
• InjuryJul 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN EXTERNAL NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT HAD PAIN. THE PATIENT'S DEVICE WAS TURNED OFF AND THE SYMPTOMS CONTINUED. THE INTERVENTION FOR THE PAIN WAS THE PATIENT WAS TRIED WITH LOW DOSE THERAPY, BUT AGAIN WAS UNSUCCESSFUL. ORIGINALLY THE PATIENT WAS SENT HOME ON HIGH DOSE SETTING, AND WOKE UP IN SEVERE PAIN AND STARTED TO PANIC. THE PATIENT CALLED 911 AND THE DEVICE WAS TURNED OFF AT 1800 ON (B)(6) 2017 AND REMAINED OFF UNTIL (B)(6) 2017. THE PARAMEDICS TOOK THE PATIENT TO THE HOSPITAL AND WAS ADMITTED ON (B)(6) 2017 AND DISCHARGED (B)(6) 2017. THE PATIENT WAS TREATED FOR PAIN AND SENT HOME. THERE WERE NO NEUROLOGICAL DEFICITS. THE PATIENT WAS SEEN IN THE CLINIC, THEY WERE IN EXTREME PAIN, BUT WERE MOVING ALL EXTREMITIES. THE PATIENT DID NOT WANT TO TURN THE DEVICE ON AGAIN. THE PATIENT TRIED THE LOW DOSE THERAPY, WHERE THEY REPORTED IMPROVEMENT. THE PATIENT GOT UP AFTER BEING PROGRAMMED TO WALK A FEW STEPS AND BEGAN TO HAVE PAIN. THE PATIENT REPORTED THAT THEY SCREAM WHEN THEY WALK. THE THERAPY WAS TURNED OFF AT THAT POINT AND THE LEADS WERE REMOVED WITHOUT COMPLICATION

  Patient problems: Pain

  MAUDE report 6716962 ↗
• MalfunctionDec 7, 2016Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  INFORMATION WAS RECEIVED FROM A REPRESENTATIVE REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT THE PATIENT NEVER RECEIVED STIMULATION. AN IMPEDANCE CHECK WAS PERFORMED AND ALL THE ELECTRODES WERE GREATER THAN 10000 OHMS. THEY CHANGED THE SNAP LID BUT STILL HAD THE SAME RESULTS. THEY CHANGED OUT THE EXTERNAL NEUROSTIMULATOR AND THE PHYSICIAN PROGRAMMER AND CONTINUED TO HAVE THE SAME RESULTS. THE PHYSICIAN PLACED ANOTHER LEAD AND THE ISSUE WAS RESOLVED. THE LEAD WAS STATED TO BE DEFECTIVE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 6152741 ↗
• MalfunctionDec 1, 2016Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Device Operates Differently Than Expected; Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Device Operates Differently Than Expected

  A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DAY PRIOR TO THE REPORT THE PATIENT HAD AN INCONTINENCE EPISODE. AFTER THIS THE PATIENT QUICKLY CHANGED THEIR SOILED CLOTHING AND PULLED TAPE OFF OF THE AREA WHERE THE TRIAL LEAD WAS SECURED TO THEIR BACK. AFTER THIS THEY WERE NO LONGER FEELING STIMULATION IN THE PAINFUL AREA AND THEY WERE EXPERIENCING BELLY STIMULATION. REPROGRAMMING WAS USED TO MOVE THE STIMULATION BACK INTO THE NEEDED AREA. IT WAS UNCLEAR IF THE TRIAL LEAD HAD MOVED. THE PATIENT STATUS WAS LISTED AS ¿ALIVE ¿ NO INJURY¿ AND THE ISSUE WAS CONSIDERED RESOLVED AT THE TIME OF THE ISSUE. THE PATIENT HAD A HISTORY OF CHRONIC PAIN AND BACK SURGERY.

  Patient problems: Pain; Therapeutic Effects, Unexpected; Undesired Nerve Stimulation

  MAUDE report 6138437 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P840001, P960009. One submission often covers many models, so check the product and lot details in each record.

• Z-2241-2026 · May 13, 2026 · Open, Classified
  Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-2240-2026 · May 13, 2026 · Open, Classified
  Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-0206-2025 · Sep 24, 2024 · Open, Classified
  Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-1691-2024 · Mar 28, 2024 · Open, Classified
  Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
• Z-0780-2024 · Dec 19, 2023 · Open, Classified
  Model A710 Intellis Clinician Programmer Application, version 2.0.97
• Z-0217-2024 · May 27, 2022 · Completed
  LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
• Z-1128-2022 · Mar 30, 2022 · Open, Classified
  Percept BrainSense Implantable Neurostimulator (INS), Model B35200
• Z-0418-2022 · Oct 19, 2021 · Open, Classified
  Model B35200 - Percept PC BrainSense Implantable Neurostimulator
• Z-0201-2022 · Sep 23, 2021 · Open, Classified
  Clinician Programmer Application (CPA) model A610 Clinician Software Application
• Z-2159-2021 · Jul 9, 2021 · Open, Classified
  Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
• Z-1368-2021 · Mar 9, 2021 · Open, Classified
  A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.46
• Z-3069-2017 · Mar 17, 2017 · Terminated
  DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to
• Z-2645-2016 · Jun 23, 2016 · Terminated
  DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain
• Z-2602-2016 · Jun 10, 2016 · Terminated
  Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

…and 13 more.